Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy
The main purposes of this study are to assess the performance characteristics of transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, and to identify the predictor variables of a positive aspirate.
Procedure: TBNA + transbronchial lung biopsy + bronchial washing
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy: Yield and Predictors of a Positive Aspirate|
- Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Evaluate the predictor variables associated with a positive TBNA result [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Compare the performance characteristics of TBNA and transbronchial lung biopsy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
|Peripheral pulmonary lesions||Procedure: TBNA + transbronchial lung biopsy + bronchial washing|
In a recent systematic literature review (Rivera PM, Mehta AC; Chest 2007; 132: 1318-1488) TBNA showed the highest sensitivity in the diagnostic bronchoscopic approach to peripheral pulmonary lesions, as compared to the other available sampling techniques (transbronchial biopsy, brushing, washings). However, the Authors conclude that the data regarding TBNA in this setting deserve cautious interpretation because of the limited number of studies and the large differences in sample size). We designed the present study to assess the performance characteristics of TBNA, alone and in comparison with those of transbronchial biopsy, in the diagnosis of peripheral pulmonary lesions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917137
|Bologna, Italy, 40133|